Who is sponsoring NCT03336346?

NCT03336346 is sponsored by Columbia University.

What condition does NCT03336346 study?

NCT03336346 studies Contraceptive Usage, HIV Infections, Drug Interaction.

What drugs are being tested in NCT03336346?

Interventions: dolutegravir, ENG implant, Efavirenz.

What is the status of NCT03336346?

NCT03336346 is currently COMPLETED.

Last reviewed 2020-02-05 · How we verify

Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana

NCT03336346 COMPLETED

The primary aim is to assess if etonogestrel (ENG) implant users taking dolutegravir (DTG) have a 20% or greater change in their ENG plasma levels, compared to women taking no antiretroviral therapy (ART). A secondary aim is to assess whether ENG implant users taking dolutegravir have significantly higher ENG plasma levels than ENG implant users taking efavirenz. This is a cross-sectional, non-randomized evaluation to compare ENG levels between 3 and 12 months post-implant insertion in three groups of women: 1) women using DTG-based ART (n=90), 2) women using EFV-based ART (n=90), and 3) women using no ART (not HIV infected) (n=90). This study will be conducted in Botswana in Southern Africa among women using the ENG implant, and involves a one-time collection of blood and questionnaire.

Details

Lead sponsor	Columbia University
Status	COMPLETED
Enrolment	148
Start date	Wed Nov 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Dec 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Contraceptive Usage
HIV Infections
Drug Interaction

Interventions

dolutegravir
ENG implant
Efavirenz

Countries

Botswana